MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY SYNCHRO-14 STRAIGHT 200-35CM; WIRE, GUIDE, CATHETER

Catalog Number	M00313010
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, coating peeled off proximally after the torque device was put over the subject guidewire.The procedure was completed successfully with no impact to the patient.
Event or Problem Description
It was reported that during the procedure, coating peeled off proximally after the torque device was put over the subject guidewire.The procedure was completed successfully with no impact to the patient.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported guidewire polytetrafluoroethylene (ptfe) coating peeling could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that the coating peeled off proximally after the torque device was put over the wire.Additional information provided by the customer indicated that torque device was used to facilitate directional manipulation of the guidewire.There was no difficulty in rotating the torque device.The coating sheared off after the torque device was put over the wire it is possible that the user backloaded the guidewire through the introducer causing the ptfe to peel.The introducer supplied with the guidewire is intended to be front loaded through the hub of the introducer, it is not recommend to backload the guidewire through the distal end of the guidewire due to risk of guidewire damage.An assignable cause of handling damage will be assigned to the reported event 'guidewire ptfe coating peeling'.

• Brand Name: SYNCHRO-14 STRAIGHT 200-35CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 20728672
• Report Number: 3012931345-2024-00203
• Device Sequence Number: 18235193
• Product Code: DQX
• UDI-Device Identifier: 07613252186922
• UDI-Public: 07613252186922
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: M00313010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown